Clinical trials are studies that involve people and are a type of clinical research. They are done to test new treatments, discover how to prevent or diagnose a disease, learn how an illness affects a person's life, and provide more information about a disease.
Developing a new treatment (or improving one that already exists) usually starts in a laboratory with research and moves to studies with human volunteers to answer questions about health.
To look for new ways to prevent illness.
To help detect diseases or conditions.
To test new types of treatments.
Clinical trials involving new medications are done in a series of steps called phases so researchers can learn about new medications in a gradual and safe way. Phase 1 is generally the first time these medications are given to people. Participants are closely monitored throughout each phase. Information and results from one phase are used to help design the next phase and the clinical trial only moves on to the next phase when the previous phase’s results were considered to be positive.
Involve 20-80 people. Healthy people take the treatment to ensure it is safe, determine how much is needed, and to determine side effects. Sometimes this phase occurs in people with a disease such as cancer.
Involve 100-300 people. People with the medical condition being studied are watched to see if the treatment works as expected and to further evaluate safety and dose.
Involve 1000-3000 people. Larger groups of volunteers are monitored to continue observing side effects and to see how well a treatment works in the long-term, how long its effects last, and how it compares to current treatments or a placebo.
Involve a large population. After a treatment is shown to work and is approved, the long-term effects and safety are studied and to determine if existing therapies should be replaced.
Depending on the research that is being done, clinical trials may happen in many different places, including:
There are a lot of people who are needed to run a clinical trial. They make sure everything goes according to plan and carefully monitor all participants. The people listed below will often be involved in clinical trials. A brief explanation of each person’s role is given.
Participant – A clinical trial simply isn’t possible without the generosity of the people who volunteer to participate.
Principal Investigator (PI) – The PI supervises the clinical trial across all the sites that are part of the clinical trial. This person is highly qualified (often a medical doctor or a dentist) with additional training in the area of clinical trials.
Clinical Research Coordinator – This person is often a nurse, and their role is to take care of participants by treating them according to the study protocol, and ensuring they understand how the study works, what their responsibilities are, how to take the study drug or use a medical device and how to complete the trial questionnaires or diaries. They make sure trial visits, tests and procedures are scheduled on time. They also provide education about the clinical trial to staff and healthcare providers who may refer their patients to the study.
Other Members of the Clinical Trial Team – This might include physician assistants, dentists, physiotherapists, nurses, pharmacists, psychologists, social workers, and any other healthcare professional that might need to help care for participants throughout a clinical trial.
Sponsor – The person, company or organization that starts and manages a clinical trial, and if required, applies for permission (e.g., from Health Canada) to conduct the trial. The sponsor may or may not provide financing for the clinical trial.
Research Ethics Board (REB)– The REB is an independent group that reviews the ethics (the right and wrong) of a clinical trial and ensures that participants in the clinical trial are protected.